Medical Device Single Audit Program Overview

Internationally-recognized subject matter expert Mark Durivage shares his expertise on the Medical Device Single Audit Program (MDSAP) requirements for certification. During this webinar, he covers the MDSAP audit process model, how to manage the audit process, how audit nonconformances are graded and reporting and response requirements.

The International Medical Device Regulators Forum (MDRF) acknowledged that to improve medical safety and oversight, a harmonized global system was necessary for auditing, inspecting and monitoring medical device manufacturers. MDSAP allows a single regulatory audit of a medical device manufacturer's quality management system by an approved auditing organization to satisfy the needs of multiple regulatory authorities.

Watch the webinar to learn how MDSAP can improve audit effectiveness, improve patient safety and potentially reduce the resource demands on your organization.

Key points:

• Identify the participating regulatory agencies, official observers and affiliate members
• Understand the benefits of MDSAP and how it works
• Identify and understand the MDSAP audit chapters
• Understand nonconformance grading and audit follow-up
• Discuss the MDSAP audit sequence

Speaker:

Mark Durivage, managing principal consultant, Quality Systems Compliance LLC

Webinar date:

March 5, 2020

Additional material covered by the webinar:

The webinar includes a Q&A session in which Mark answers questions, such as:

• What does an MDSAP audit cost?
• How do the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) affect MDSAP?

The webinar also shares several UL eLearning courses, developed with Mark Durivage, on the topic of MDSAP.